JP2023065443A - Intravascular data visualization methods - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide intravascular data collection systems, and methods for software-based visualization and display of intravascular data relating to detected side branches and detected stent struts.

SOLUTION: Levels of stent malapposition can be defined using a user interface such as a slider, toggle, button, field, or other interface to specify how indicia are displayed relative to detected stents. In addition, the disclosure relates to methods for automatically providing a two- or three-dimensional visualization suitable for assessing a side branch and/or guide wire during stenting. The method can be based on one or more of a computed side branch location, a branch takeoff angle, one or more stent locations, and one or more lumen contours.

SELECTED DRAWING: Figure 2

COPYRIGHT: (C)2023,JPO&INPIT

Description

This application is filed Jul. 25, 2015 from U.S. Provisional Application No. 62/196,997, filed July 25, 2015. S. C. 119(e), the preamble of which is incorporated herein by reference.
The present disclosure relates generally to intravascular measurement and feature detection and related diagnostic methods and devices.

Coronary artery disease is one of the leading causes of death worldwide. The ability to more adequately diagnose, monitor, and treat coronary artery disease can have life-saving importance. Intravascular optical coherence tomography (OCT) is a catheter-based imaging modality that uses light to see through the walls of coronary arteries to produce images thereof for study. Utilizing coherent light, interferometry, and micro-optics, OCT can provide video-rate in vivo tomography within diseased vessels with micrometer-level resolution. The ability to see subsurface structures with high resolution using fiber optic probes makes OCT particularly useful for minimally invasive imaging of internal tissues and organs. This level of detail enabled with OCT enables clinicians to diagnose and monitor the progression of coronary artery disease. OCT images provide high-resolution visualization of coronary artery morphology and can be used alone or in combination with other information such as angiographic data and other subject data sources to assist in planning stent delivery, etc. Diagnosis and planning can be assisted.

OCT imaging of parts of a patient's body provides a useful diagnostic tool for physicians and others. For example, intravascular OCT imaging of coronary arteries may reveal the location of narrowing or stenosis. This information helps cardiologists choose between invasive coronary artery bypass surgery and less invasive catheter-based procedures such as angioplasty or stent delivery. Although a common option, stent delivery has its own associated risks.

A stent is a tubular structure that is often formed of mesh. A stent can be inserted into a blood vessel and expanded to counteract a stenotic condition that constricts blood flow. Stents are typically made of metal or polymer frameworks. A stent can be placed at the site of the stenosis via a catheter. During a cardiovascular procedure, a stent can be delivered over a guidewire through a catheter to the stenotic site and expanded using a balloon. Typically, stents are expanded using a preset pressure to widen the lumen of a stenosed vessel. Angiography, intravascular ultrasound, and OCT systems can be used in combination or alone to facilitate stent delivery planning and stent placement.

There are several factors that affect patient outcome when deploying a stent. In some procedures, the stent must be expanded to a diameter that corresponds to the diameter of the adjacent healthy vessel segment. Overexpansion of a stent can cause extensive damage to the vessel, making it susceptible to dissection, disarticulation, and intra-mural hemorrhage. A stent under expansion may cause the vessel to expand poorly. If portions of the stent fail to contact the vessel wall, the risk of thrombosis may be increased. An underinflated or malapposed stent may not restore normal flow. Once the stent is in place, stent malapposition and stent under expansion can cause a variety of problems. In addition, flow-restricting stenoses are often present near vascular side branches.

Side branches may be partially or completely occluded or "jailed" by stent struts. For example, this can occur when a stent is placed in a main vessel to address a stenosis or other disease. Side branches are extremely important for carrying blood to downstream tissues. Thus, jailing can have undesirable ischemic effects. The ischemic effects of restraint are doubled when multiple side branches are impacted or when the occluded surface area of a single branch is significant.

There are other challenges associated with stent placement and related procedures. Visualizing stent placement relative to the vessel wall using an angiographic system is challenging to do by inspection.

The present disclosure addresses these and other challenges.

In part, the present disclosure relates to systems and methods for visualizing intravascular data such as detected side branches and detected stent struts. Data can be obtained using an intravascular data acquisition probe. A probe can be pulled back through the vessel and data collected thereon. In one embodiment, the probe is an optical probe, such as an optical coherence tomography (OCT) probe. In one embodiment, the probe is an intravascular ultrasound probe (IVUS), such as an optical coherence tomography probe. In various embodiments of the present disclosure, the stent can be visualized relative to the side branch. This is an important feature. This is because it is typically desirable to avoid stenting the side branch during stent deployment. The systems and methods described herein facilitate visualization of the stent in the side branch using various user interfaces and stent strut and side branch representations based on the detection of these features in the collected intravascular data. to

In part, the present disclosure relates to intravascular data acquisition systems and software-based visualization and display of intravascular data regarding detected side branches and detected stent struts. A user interface, such as a slider, toggle, button, field, or other interface that specifies how markings are displayed for detected stent struts, can be used to define the level of stent misalignment. can. In addition, the present disclosure relates to methods for automatically providing two- or three-dimensional visualization suitable for assessing side branch and/or guidewire location during stenting. The method can use one or more of the calculated side branch locations, branch takeoff angles, one or more stent strut locations, and one or more lumen contours.

In part, the present disclosure relates to systems and methods for stent planning, and otherwise to systems and methods for generating and displaying diagnostic information of interest. The present disclosure also relates to the generation of various indicators and their integration with the display of image data. As an example, a longitudinal indicator such as an apposition bar can be used alone or in conjunction with a stent strut indicator to provide images or OCT generated for them for diagnostic processes such as stent planning. It can be overlaid on top of an angiographic frame co-recorded with an intravascular data set, such as a set of operating lines.

In part, the present disclosure relates, in one embodiment, to systems and methods for displaying results of data analysis applied to intravascular data sets to users of intravascular data acquisition systems and angiography systems. In part, the present disclosure provides one or more of the vessels so that regions of interest, such as regions of stent apposition and other regions, can be easily found and understood on OCT and angiographic images. A graphic user interface (GUI) is described that provides a user interface and graphical data representation that can be applied to more images or angiographic images.

In part, the present disclosure relates to a data acquisition system, such as an intravascular data acquisition system suitable for use within a cath lab, such as an optical coherence tomography system. In part, the present disclosure relates to data acquisition systems including processors suitable for displaying intravascular image data. The displayed image data includes data or images generated based on depth measurements. In one embodiment, the image data is generated using optical coherence tomography. The system may provide data on stent malalignment in longitudinal mode on a stent strut basis or on a stent, no stent or stent malalignment level of potential interest for one or more stents within a vessel. A user interface for display of intravascular information may also be displayed, such as a bar with corresponding regions. As a non-limiting example, one or more indicators, such as a longitudinal indicator, can be generated in response to the stent detection process and lumen boundary detection and displayed for angiographic, OCT, and IVUS images. can. The user can view these to plan stent delivery and dilate or adjust stent delivery by reviewing co-recorded OCT and angiographic images with relevant indications of interest.

The present disclosure relates, in part, to computer-based visualization of one or more viewing angles or orientations with respect to one or both of the guidewire and side branch and stent position within the vessel. The OCT data is used to visualize the stent and subsequently displayed as part of the stent struts or stent as part of one or more graphic user interfaces (GUIs). Side branches and guidewires can be similarly detected and displayed. In one embodiment, the disclosure includes a computer algorithm that visualizes detected intravascular features and displays them in an optimized or optimal manner suitable to enhance their diagnostic value to the end user. provide a software-based method that can The GUI can include one or more views of the vessel generated using OCT ranging and oriented to locations relative to the side branch or guidewire to increase diagnostic value or ease of use for the end user.

In part, the present disclosure relates to methods of visualizing intravascular information obtained using intravascular data collection probes. The method comprises: receiving intravascular data for a vessel comprising a plurality of image frames; storing the intravascular data in a memory device of an intravascular data acquisition system; detecting a lumen for each image frame; determining a first viewing angle for at least one of the side branch or the lumen; and displaying a three-dimensional visualization of the at least one of the side branch or the lumen. include. In one embodiment, the lumen is the lumen boundary. In one embodiment, lumen contours and lumen boundaries are interchangeable.

In one embodiment, the method further comprises displaying a three-dimensional flythrough for at least one of the side branch or the lumen. In one embodiment, the intravascular data is optical coherence tomography data. In one embodiment, each image frame includes a set of scanlines. In one embodiment, the method further comprises detecting a plurality of stent struts. In one embodiment, the method further comprises detecting one or more guidewires.

In one embodiment, the method further includes determining a second viewing angle for the plurality of stent struts. In one embodiment, the method further includes determining a third viewing angle for the one or more guidewires. In one embodiment, the three-dimensional visualization is oriented at a first viewing angle. In one embodiment, the three-dimensional flythrough is user controllable in one or more directions using an input device.

In one embodiment, the method includes determining the side branch arc of the lumen contour, estimating the side branch orientation by fitting the cylinder constrained by the side branch arc, and selecting the orientation of the fitted cylinder. further includes In one embodiment, the method includes determining an intermediate frame of an image frame of intravascular data, determining an intermediate arc position on the intermediate frame, and pointing toward an intravascular imaging probe for the intermediate frame. It further includes setting an initial camera position for the three-dimensional view to attach.

In part, the present disclosure relates to a processor-based system that controls stent apposition threshold based on user input. The system includes one or more memory devices and a computing device in communication with the one or more memory devices, the one or more memory devices containing instructions executable by the computing device, these instructions causing the device to display a user interface including stent strut apposition threshold controls, including user-selectable inputs, and storing the user-inputted stent strut apposition thresholds in one or more memory devices, collected using an intravascular probe; Detecting one or more stents within an intravascular data set, displaying one or more stents and one or more markings associated with the one or more stents, the markings indicating a level of stent strut apposition, wherein the level of stent strut apposition is Determined using user selectable input. In one embodiment, the stent strut apposition threshold control is a slider.

In one embodiment, the user-selectable input is one or more values of a slider. In one embodiment, the indicia are one or more colors. In one embodiment, the slider is configured to define three alignment thresholds. In one embodiment, the stent strut apposition threshold control measures stent strut apposition relative to the anterior surface of the stent strut. In one embodiment, the stent strut stent apposition threshold control is selected from the group consisting of form-fillable fields, buttons, toggle controls, dials, and numerical selection inputs.

The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
The drawings are not necessarily to scale, emphasis instead being generally placed on the illustrative principles. The drawings are to be considered illustrative in all aspects and are not intended to limit the disclosure, the scope of which is defined solely by the claims.

1 shows a schematic diagram of an intravascular imaging and data acquisition system in accordance with an exemplary embodiment of the present disclosure; FIG. 4 is a flow chart illustrating a framework for visualization of a stent within a branch vessel in accordance with an exemplary embodiment of the present disclosure; FIG. 12A is a schematic diagram illustrating virtual camera positions for visualizing a side branch vessel in accordance with an exemplary embodiment of the present disclosure; FIG. 12A is a schematic diagram illustrating virtual camera positions for visualizing a side branch vessel in accordance with an exemplary embodiment of the present disclosure; FIG. 12A is a schematic diagram illustrating virtual camera positions for orthogonal viewing of a side branch ostium in accordance with an exemplary embodiment of the present disclosure; 3D is a three-dimensional rendering of a stent strut constraining a side branch ostium in accordance with an exemplary embodiment of the present disclosure; FIG. 12A is a side view of a three-dimensional rendering of a main vessel having side branches with a stent and multiple guidewires positioned within the main vessel, in accordance with an exemplary embodiment of the present disclosure; 3B is a fly-through three-dimensional rendering of the side branch lumen with the virtual camera angle directed along the longitudinal axis of the side branch as shown in FIG. 3A, according to an exemplary embodiment of the present disclosure; 3B is a fly-through three-dimensional rendering of the main vessel lumen with the virtual camera angle oriented along the longitudinal axis of the main vessel as shown in FIG. 3A, according to an exemplary embodiment of the present disclosure; FIG. 4 is a schematic diagram illustrating virtual camera positioning with an intermediate frame/intermediate arc model in accordance with an exemplary embodiment of the present disclosure; Fig. 10 is a schematic diagram showing a virtual camera positioning using a cylinder model; FIG. 11 is a schematic diagram illustrating side branch size estimation according to an exemplary embodiment of the present disclosure; FIG. 12 is a schematic diagram showing side branch locations and color coding the degree of side branch occlusion in accordance with an exemplary embodiment of the present disclosure; 4 is a user display showing a perspective view of a three-dimensional rendering of a blood vessel in accordance with an exemplary embodiment of the present disclosure; FIG. 3A is a side view of a three-dimensional rendering of a blood vessel in accordance with an exemplary embodiment of the present disclosure; 4 is a cross-sectional B-mode OCT intravascular image in accordance with an exemplary embodiment of the present disclosure; 4 is a longitudinal L-mode OCT intravascular image in accordance with an exemplary embodiment of the present disclosure; FIG. 13A is a side view of a three-dimensional rendering of a blood vessel showing constrained side branches in accordance with an exemplary embodiment of the present disclosure; 4 is a cross-sectional B-mode OCT intravascular image in accordance with an exemplary embodiment of the present disclosure; 4 is a longitudinal L-mode OCT intravascular image in accordance with an exemplary embodiment of the present disclosure; 3 is a fly-through three-dimensional rendering of a blood vessel in accordance with an exemplary embodiment of the present disclosure; 4 is a cross-sectional B-mode OCT intravascular image in accordance with an exemplary embodiment of the present disclosure; 4 is a longitudinal L-mode OCT intravascular image in accordance with an exemplary embodiment of the present disclosure; 3 is a fly-through three-dimensional rendering of a vessel showing constrained side branches in accordance with an exemplary embodiment of the present disclosure; 4 is a cross-sectional B-mode OCT intravascular image in accordance with an exemplary embodiment of the present disclosure; 4 is a longitudinal L-mode OCT intravascular image in accordance with an exemplary embodiment of the present disclosure; FIG. 13A is a side view of a three-dimensional rendering of a blood vessel showing a released side branch in accordance with an exemplary embodiment of the present disclosure; FIG. 13B is a cross-sectional B-mode OCT intravascular image in accordance with an exemplary embodiment of the present disclosure; FIG. 13C is a longitudinal L-mode OCT intravascular image in accordance with an exemplary embodiment of the present disclosure; FIG. 13D is an enlarged view of FIG. 13A showing a side branch ostium and torn stent struts according to an exemplary embodiment of the present disclosure; FIG. 13B shows a graphical user interface display of an intravascular data acquisition system illustrating a three-dimensional skin and wireframe view of a deployed stent in accordance with an exemplary embodiment of the present disclosure; FIG. FIG. 13B shows a graphical user interface display of an intravascular data acquisition system illustrating a three-dimensional skin and wireframe view of a deployed stent in accordance with an exemplary embodiment of the present disclosure; FIG. FIG. 13B shows a graphical user interface display of an intravascular data acquisition system illustrating a three-dimensional skin and wireframe view of a deployed stent in accordance with an exemplary embodiment of the present disclosure; FIG. FIG. 13B shows a graphical user interface display of an intravascular data acquisition system illustrating a three-dimensional skin and wireframe view of a deployed stent in accordance with an exemplary embodiment of the present disclosure; FIG. FIG. 12B shows a three-dimensional fly-through display of a wireframe view of a deployed stent according to an exemplary embodiment of the present disclosure; FIG. A user interface suitable for adjusting the alignment threshold, which then determines when to display alignment and indications/indicia (colors, symbols, etc.) for use in accordance with exemplary embodiments of the present disclosure. 4 is a user interface that controls the threshold used by the intravascular data acquisition system when determining . A user interface suitable for adjusting the alignment threshold, which then determines when to display alignment and indications/indicia (colors, symbols, etc.) for use in accordance with exemplary embodiments of the present disclosure. 4 is a user interface that controls the threshold used by the intravascular data acquisition system when determining . A user interface suitable for adjusting the alignment threshold, which then determines when to display alignment and indications/indicia (colors, symbols, etc.) for use in accordance with exemplary embodiments of the present disclosure. 4 is a user interface that controls the threshold used by the intravascular data acquisition system when determining .

In part, the present disclosure relates to systems and methods for visualizing intravascular data such as detected side branches and detected stent struts. Data can be obtained using an intravascular data acquisition probe. A probe can be pulled back through the vessel and data collected thereon. Such pullbacks and associated data collection are used to plan stent deployment or to evaluate deployed stents. The intravascular data resulting from the pullback can be used in a variety of ways, such as visualizing various vessel regions, features, and stents placed in relation to them.

In various embodiments of the present disclosure, the stent can be visualized relative to the side branch. This is an important feature. This is because during stent deployment it is typically desirable to avoid stenting the side branch. Based on the detection of these features in the intravascular data it collects, the systems and methods described herein facilitate visualization of the stent within the side branch using various user interfaces and representations of stent struts and side branches. to

In part, the present disclosure relates to intravascular data acquisition systems such as OCT, IVUS, and other imaging modalities, and diagnostic information such as stent malapposition or other indications. Concerning generation and visualization. The present disclosure provides the user with parameters of interest and Various user interface features that allow thresholds to be specified. The parameters can be used to adjust or change how and when graphical elements, such as graphic elements suitable for showing diagnostic information of interest, such as apposition level to regions within the vessel and stent position, are displayed. In one embodiment, those regions may contain the side branches to be detected. Stent strut indicators can also be used.

Suitable diagnostic information can include, for example, stent misalignment information relative to vessel walls or luminal boundaries and other intravascular diagnostic information or other information generated to facilitate stent delivery planning. The system includes a processor configured to communicate with and send instructions to the graphical user interface. Using one or more software programs, display indicators such as color-coded stent struts or symbols or other indications displayed at detected stent strut locations, stent location and orientation relative to side branches, and stent apposition. Perform one or more of the stent apposition levels based on user-specified criteria for when is displayed.

Also disclosed herein are systems and methods for visualizing stents and other medical devices relative to side branches to avoid their constraint with blood vessels. One or more software modules can be used to detect side branch locations, lumen contours, and stent strut locations. One or more viewing angles or orientations can be generated to help the user visualize when side branch constraint may occur.

In order to improve blood flow in a constrained side branch, it may be necessary to open clusters of cells within a deployed stent using a balloon. The balloon guidewire is typically crossed over the constrained side branch ostium at the most distal (eg, downstream) location possible. Obtaining a distal guidewire position results in stent struts being pushed proximal (e.g., upstream) of the side branch ostium, which is a flow obstruction distal to the higher-flow of the side branch ostium. (flow disruptions). Therefore, clear and rapid visualization of guidewire position relative to stent and side branch is clinically advantageous.

FIG. 1 is suitable for performing various steps of the present disclosure, such as displaying detected stent struts, side branches, and guidewires and their associated indicia and orientation angles. system. Various user interface features are described herein for viewing and evaluating visual representations of intravascular information. These user interfaces include one or more movable elements that the user can control using a mouse, joystick, or other control device, and that can be operated using one or more processor and storage elements. can include For example, the sliders of Figures 15A-15C can be so controlled.

During the stent delivery planning procedure, the level and location of apposition, the user can refer to OCT and annotated angiography to further expand or move the stent as part of the delivery plan. These system features and methods can be implemented using the system 5 shown in FIG.

FIG. 1 illustrates a system 5 that includes various data collection subsystems suitable for collecting data or detecting or sensing characteristics or otherwise diagnosing the condition of a subject 10 . In one embodiment, subject 10 is placed on a suitable support 12 such as a table bed or chair or other suitable support. Typically, subject 10 is a human or other animal with a particular area of interest 25 .

Data acquisition system 5 includes a non-invasive imaging system, such as nuclear magnetic resonance, X-ray, computer-assisted tomography, or other suitable non-invasive imaging technique. An angiographic system 20 is shown as suitable for producing cines, to serve as a non-limiting example of such a non-invasive imaging system. Angiography system 20 may include a fluoroscopy system. Angiography system 20 performs a pullback procedure using probe 30 such that blood vessels within region 25 of subject 10 are imaged angiographically in one or more imaging techniques, such as OCT or IVUS. During the process, the subject 10 is configured to non-invasively image the subject 10 such that frames of angiographic data, typically in the form of frames of image data, are generated.

Angiography system 20 communicates with an angiography data storage and image management system 22, which in one embodiment can be implemented as a workstation or server. In one embodiment, data processing for acquired angiographic signals is performed directly at the detector of angiographic system 20 . Images from system 20 are stored and managed by angiographic data storage and image management system 22 .

In one embodiment, system server 50 or workstation 85 handles the functionality of system 22 . In one embodiment, the entire system 20 produces electromagnetic radiation, such as X-rays. System 20 also receives such radiation after passing through subject 10 . Data processing system 22 then uses the signals from angiography system 20 to image one or more regions of subject 10 , including region 25 .

As shown in this particular example, the region of interest 25 is a subset of the vasculature, such as a particular blood vessel, or peripheral vasculature. This can be imaged using OCT. A catheter-based data acquisition probe 30 is introduced into the subject 10 and positioned within the lumen of a particular blood vessel, such as a coronary artery. Probe 30 may vary, such as, for example, OCT probes, FFR probes, IVUS probes, probes that combine features of two or more of the foregoing probes, and other probes suitable for imaging in blood. can be any kind of data collection probe. Probe 30 typically includes a probe tip, one or more radiopaque markers, optical fibers, and torque wires. Additionally, the probe tip includes one or more data acquisition subsystems such as optical beam directors, acoustic beam directors, pressure detection sensors, other transducers or detectors, and combinations of the foregoing.

For probes that include an optical beam director, optical fiber 33 optically communicates with the probe that includes the beam director. A torque wire defines a bore in which the optical fiber is placed. In FIG. 1, optical fiber 33 is shown without a torque wire surrounding it. In addition, probe 30 also includes a sheath, such as a polymer sheath (not shown) forming part of the catheter. An optical fiber 33, which in the context of an OCT system is part of the sample arm of the interferometer, is optically coupled to a patient interface unit (PIU) 35 as shown.

Patient interface unit 35 includes a probe connector suitable for receiving the end of probe 30 and being optically coupled thereto. Typically, data collection probe 30 is disposable. PIU 35 includes appropriate joints and elements based on the type of data acquisition probe used. For example, a combination of OCT and IVUS data acquisition probes requires OCT and IVUSSPIU. The PIU 35 also typically includes a motor suitable for pulling back the torque wires, sheaths and optical fibers 33 placed therein as part of the pullback procedure. In addition to being pulled back, the probe tip is also typically rotated by the PIU 35 . In this way, the blood vessels of the subject 10 can be imaged longitudinally or via a transverse plane. Probe 30 may also be used to measure certain parameters such as flow reserve ratio (FFR) or other pressure measurements.

PIU 35 is then connected to one or more intravascular data acquisition systems 40 . Intravascular data acquisition system 40 can be an OCT system, an IVUS system, other imaging systems, and combinations of the foregoing. For example, the system 40 in the context of the probe 30, which is an OCT probe, can include an interferometer sample arm, an interferometer reference arm, a photodiode, a control system, and a patient interface unit. Similarly, as another example, in the context of an IVUS system, intravascular data acquisition system 40 may include ultrasound signal generation and processing circuitry, noise filters, rotatable joints, motors, and interface units. can be done. In one embodiment, data acquisition system 40 and angiography system 20 have a shared clock or other type of timing signal configured to synchronize the angiography video frame timestamps and OCT image frame timestamps.

In addition to the invasive and non-invasive image data acquisition systems and devices of FIG. 1, various other types of data can be collected regarding the subject's region 25 and other parameters of subject interest. For example, data collection probe 30 may include one or more pressure sensors, such as pressure wires. Pressure wires can be used without the addition of OCT or ultrasound components. Pressure readings can be obtained along a segment of a vessel within region 25 of subject 10 .

Such readings can be relayed by a wired connection or via a wireless connection. As shown in the Flow Reserve FFR Data Acquisition System, a wireless transceiver 47 receives pressure readings from the probe 30 and transmits them to the system to obtain FFR measurements or more locations along the measured vessel. configured to generate One or more of the displays 82, 83 may also be used to show angiographic frames of data, OCT frames, user interfaces for OCT and angiographic data, and other controls and features of interest.

Intravascular image data, such as frames of intravascular data generated using data acquisition probe 30 , can be routed to data acquisition processing system 40 coupled to the probe via PIU 35 . Non-invasive image data generated using angiography system 22 is transmitted to, stored in, and distributed to one or more servers or workstations, such as co-registration server workstation 85 . can be processed by A video frame grabber device 55, such as a computer board configured to capture angiographic image data from system 22, may be used in various embodiments.

In one embodiment, server 50 includes one or more co-recording software modules 67 stored in memory 70 and executed by processor 80 . Server 50 may include other typical components for processor-based computing servers. Alternatively, it receives generated image data, subject parameters, and other information generated by one or more of the system devices or components shown in FIG. As such, more databases, such as database 90, can be configured. Although database 90 is shown connected to server 50 while stored in memory at workstation 85, this is but one exemplary configuration. For example, software module 67 may run on a processor at workstation 85 and database 90 may be located in memory of server 50 . As an example, a device or system used to execute various software modules is provided. In various combinations, the hardware and software described herein can be used to acquire frames of image data, process such image data, and register such image data.

As referred to elsewhere herein, software module 67 may be used to process image data or facilitate simultaneous recording of different types of image data by other software-based components 67. It may include software such as pre-processing software, transforms, matrices, and other software-based components that enable or otherwise respond to patient triggers to perform such simultaneous recording. The module provides lumen detection using scanline-based or image-based approaches, stent detection using scanline-based or image-based approaches, indicator generation, apposition bar generation for stent planning, avoiding confusion with dissection guidewire shadow indicators, side branch and missing data, and others.

Database 90 may be configured to receive and store angiographic image data 92 , such as image data generated by angiographic system 20 and acquired by frame grabber 55 server 50 . Database 90 may be configured to receive and store OCT image data 95 , such as image data generated by OCT system 40 and acquired by frame grabber 55 server 50 .

Additionally, subject 10 can be electrically coupled to one or more monitors, such as monitor 49, via one or more electrodes. Monitor 49 may include, but is not limited to, an electrocardiogram monitor configured to generate data regarding heart function and indicate various conditions of the subject, such as systole and diastole. Knowing the cardiac phase, which can be used to aid in tracking vascular centerlines, such as the geometry of the heart, including the coronary arteries, provides approximately are the same.

Therefore, if the angiographic data spans several cardiac cycles, primary alignment of vessel centerlines at the same cardiac phase may help track the centerline through pullback. In addition, since most of the heart's motion occurs during systole, vasomotion is expected to be higher near systole and taper off towards diastole. This provides data to one or more software modules as an indication of the amount of motion expected between successive angiographic frames. One or more software modules use knowledge of expected motion to improve tracking and vessel centerline quality by enabling fit constraints based on expected motion.

The use, or lack thereof, of directional arrowheads in any given figure is not intended to limit or mandate the directions in which information may flow. For a given connector, for example, the arrows and lines shown connecting the elements shown in FIG. can be done. Connections may include any suitable data transmission connection, such as optical, wired, power, wireless, or electrical connections.

One or more software modules may be used to process frames of angiographic data received from an angiographic system, such as system 22 shown in FIG. Various software modules, which may include, without limitation, software, components thereof, or one or more steps of a software-based or processor-implemented method, may be used in any given embodiment of the present disclosure. can be done.

Intravascular Data Visualization In one aspect, a computer-implemented method is provided for creating an optimal three-dimensional visualization for evaluating an endovascular treatment site. In various embodiments, the method automatically determines the optimal camera location and view perspective based on collateral morphology to facilitate visualization of the treatment site. The method can include detection of medical devices (eg, stents) and associated deployment devices (eg, guidewires). This feature is particularly useful in bifurcation stenting to identify constrained side branches and help the clinician modify stent cells to relieve obstructions. Using the software module 67 of the intravascular data acquisition system to perform one or more of the steps described herein, various operations described herein with respect to side branches, guidewires and other forms of intravascular data visualization can be performed. A method can be implemented.

Referring to FIG. 2, in one embodiment, computer-implemented method 100 includes one of the following data gathering steps: side branch detection 102, lumen contour detection 104, stent strut detection 106, and guidewire detection 108. Including above. Side branch detection and lumen detection can include substeps of determining the optimal viewing angle 110 based on the angle at which the side branch joins the main vessel. As described in more detail herein, these inputs are used to create a three-dimensional visualization of the treatment site, such as a fly-through display. Different viewing angles include, as non-limiting examples, side view, perspective view, top view, side branch fly-through view, main vessel fly-through view, and orthogonal view. Includes an orthogonal ostium view.

Referring to FIG. 3A, in one embodiment a virtual camera 150 is generated for one or more side branches 152 within a main vessel 154 . The virtual camera is positioned at the appropriate viewing angle for three-dimensional visualization of the side branch looking in the direction of the main vessel. Referring to FIG. 3B, in one mode of operation, camera orientation 156 is selected to be parallel to the longitudinal axis of the side branch. Referring to FIG. 3C, in other modes, camera orientation 156 is selected to be orthogonal to the surface of main vessel 154 and/or orthogonal to side branch ostium 158 . These viewing angles are exemplary and any suitable viewing angle can be used.

Referring to FIG. 3D, in another embodiment, the user can visualize the stent struts 160 across the side branch ostium 158 . To better see the constraining stent struts, the side branch can be removed from the display so that the user can more clearly visualize the side branch ostium and the strut struts across the side branch ostium. In FIG. 3D, the virtual camera is orthogonal to the side branch ostium and looking through the ostium to the lumen of the main vessel where the stent will be placed.

FIG. 4A is a side view of a three-dimensional rendering of a main vessel 154 with side branches 152. FIG. In this embodiment, main vessel guidewire 164, side branch guidewire 166, and stent struts 160 are visible.

FIG. 4B is a three-dimensional rendering looking down the side branch 152 (eg, flythrough) toward the main vessel 154 . In this embodiment, camera 150b is oriented along the direction of the lateral branch angle as shown in FIG. 4A. Side branch guidewire 164, main vessel guidewire 166, and stent struts 160 are visible.

FIG. 4C is a three-dimensional flythrough of main vessel 154 . In this embodiment, camera 150m is oriented along the longitudinal axis of the main branch, as shown in FIG. 4A. Side branch guidewire 164, main vessel guidewire 166, and stent struts 160 are visible.

In various embodiments, the method can include automatically identifying an initial camera position. Referring to FIG. 5A, in one embodiment, side branch orientation is estimated by finding an intermediate frame 170 in the imaging data (eg, OCT data) and the intermediate arc position on the intermediate frame. Intermediate frame 170 is the center of side branch lumen 172 within a given imaging frame. Intermediate arc 174 is the center of the arc that defines side branch lumen contour 176 . In the preferred embodiment, the mid-arc position is used as the initial camera position 178, ie, where the virtual camera is positioned. An initial camera orientation, ie, where the virtual camera is aimed, is then automatically selected. In a preferred embodiment, the camera is directed toward the imaging catheter 180 for its mid-frame, providing the clinician with a view down the side branch lumen 172 and toward the main vessel lumen 182 . However, the camera can be oriented in any direction.

Referring to FIG. 5B, in another embodiment, camera positioning is determined by fitting cylinder 184 into side branch lumen 174 . Side branch orientation 186 is then estimated using the arc of cylinder 184, which is a proxy for the arc of the side branch lumen contour. In a preferred embodiment, camera 178 is positioned along the axis of side branch 186 . An initial camera orientation is then automatically selected. In a preferred embodiment, the camera is automatically directed down the cylinder axis 186 toward the main vessel lumen 182 . However, the camera can be oriented in any direction.

The present disclosure provides computer-implemented methods for enhanced visualization of medical devices such as guidewires and stents on user displays. This enhanced visualization helps the clinician assess the treatment site adjacent to the placed medical device and assess whether further intervention is required. For example, it is particularly important for the clinician to know when the guidewire is positioned inside (ie, the lumen) of the stent or outside (ie, the abluminal) side of the stent. As another example, it is often necessary to open clusters of cells within a stent placed using a balloon to improve blood flow in a constrained side branch. The balloon guidewire is typically crossed over the constrained side branch ostium as distally (eg, downstream) as possible. Obtaining a distal guidewire position results in the stent struts being pushed proximally (eg, upstream) of the side branch ostium, which minimizes flow obstruction distal to the larger flow of the side branch ostium.

Stent struts and guidewires are automatically detected within the imaging data and shown on the user display to provide the clinician with comprehensive visualization of the treatment site. Stent struts and guidewires can be displayed in a visually distinct manner, such as by using different colors, to allow for quick interpretation by the clinician. In some embodiments, the guidewire can be shown in different colors according to its luminal/extraluminal position relative to the stent. For example, extraluminal guidewires may be displayed in red as a warning, and lumenal guidewires may be displayed in yellow. This visualization can help clarify the point at which the guidewire traverses the constrained side branch, and can help alert the user to a guidewire inadvertently positioned extraluminally in the stent segment of the main branch. can also help.
In other embodiments where multiple guidewires are used, each guidewire may be shown in a different color, or the guidewires may be sorted by color. For example, side branch guidewires may be shown in one color and main vessel guidewires may be shown in another color. In other embodiments, the guidewire can be shown in one color if it traverses the main vessel lumen, and the portion of the same guidewire that traverses a side branch can be shown in a different color. In other embodiments, the guidewire can be shown in different colors when the guidewire traverses the side branch ostium or when the guidewire passes through the stent cell.

Similarly, some or all of the stent and/or stent struts can be shown in different colors to indicate potential problems, such as struts constraining side branches. For example, struts across the side branch ostium can be shown in red, while struts adjacent to the vessel wall can be shown in blue.

In other embodiments, the side branch ostium can be defined by visual indicia, such as a polygon highlighted around the edge of the side branch ostium. The visual mark can be one color for unoccluded side branch ostia and another color for blocked side branch ostia.

Color coding can also be applied to the stent struts to clarify their position relative to the virtual camera. In Figures 4A-4C, it can be difficult to see which stent is placed over the side branch ostium versus which stent is placed against the main vessel wall. However, referring to FIG. 3B, following automatic detection of individual struts and vessel lumens, struts appear gray or white, which is less relevant for visualization of wire re-crossing. can be assigned a de-emphasizing color or they can be removed entirely, whereas struts that constrain more relevant collaterals can be assigned an emphasizing color such as red. .

Color is just one example of visual indicia that can be used in accordance with the disclosure. For example, indicia may be bars, boxes, any other suitable visualizable display elements, symbols or icons. Preferably, the markings quantify the degree of any side branch occlusion, eg, by color coding, shading, and/or variable opacity of the markings.

Evaluation of Side Branch Obstruction The present invention also provides a computer-implemented method for calculating and visualizing the degree of branch obstruction. Several methods can be used to calculate branch blockage due to the presence of pathology (eg, stenosis) or medical intervention (eg, restraint).

ここで、Ｄ（ｉ＋１）は、近位基準プロファイル直径であり、Ｄ（ｉ）は、遠位基準プロファイル直径であり、ここで、Ｄ_ｂ（ｉ）は、推定された真の枝直径であり、εは、経験的に決定されるような２．０～３．０の間の値を有する冪乗則スケーリング指数である。 In one embodiment, the baseline vessel diameter method is used to assess side branch obstruction. FIG. 6 shows a main vessel 200 with a stenosis 202. FIG. A side branch 204 is also shown. A reference profile can be created for the main vessel 206 and/or a reference profile can be created for the side branch 208 . Using the reference profile (dotted line) 208, the estimated branch diameter can be calculated by using the distal and proximal reference profiles. In one embodiment, the power law is given by the following equation.

where D(i+1) is the proximal baseline profile diameter, D(i) is the distal baseline profile diameter, and D _b (i) is the estimated true branch diameter. , ε is a power law scaling index with a value between 2.0 and 3.0 as determined empirically.

ここで、Ｄ_ｂ（ｉ）は、推定された真の枝直径であり、Ｄ_ＯＣＴ（ｉ）は、ＯＣＴによって測定された実際の枝直径である。 The difference between the estimated branch diameter and the actual branch diameter detected by OCT imaging provides the level of branch occlusion. In one embodiment, the level of branch occlusion is given by the formula:

where D _b (i) is the estimated true branch diameter and D _OCT (i) is the actual branch diameter measured by OCT.

In one embodiment, the maximum diameter frame method is used to assess side branch occlusion. Estimate the branch diameter using the maximum diameters in the main vessel segments distal and proximal to the current branch instead of using the reference profile.

In one embodiment, the flow method is used to assess side branch occlusion. If a Virtual Flow Reserve (VFR) is used, the flow entering each branch can be estimated. Differences in flow down a given side branch due to the difference between the OCT-based branch diameter Flow _OCT (i) and the true branch diameter Flow _b (i) add to the effect on flow due to occluded side branches. It is a typical display. By using either the reference vessel profile in the distal and proximal segments or the re-diameter frame, the true branch diameter can be calculated using one of the methods described above. The flow method is given as the following equation.

In various embodiments, visual indicia, such as color coding, are used to indicate side branch flow occlusion on the user display. The indicia can be encoded to give the level of side branch occlusion. These indicia can also be set based on user input via a user interface. FIG. 7 is a schematic diagram of an exemplary user display. The display shows a main vessel 200 with a stenosis 202 and three side branches 210,212,214. A highly occluded side branch 212 is defined by a different indicia (e.g. red) than a moderately occluded side branch 210 (e.g. orange) and a low occluded/unobstructed side branch 214 (e.g. yellow). .

FIG. 8 shows a user display depicting a perspective view of a three-dimensional rendering of blood vessel 300 according to an embodiment. Markings defining guidewire 302, stent struts 304, and constrained side branch 306 are visible. The user display includes a menu 310 for showing/hiding the guidewire, a menu 312 for selecting vessel features to display, and a menu 314 for selecting the virtual camera angle of the display. A user can switch between multiple viewing angles on the user display. Additionally, the user can switch between different side branches on the user display, for example, by selecting a particular side branch and/or by selecting a camera associated with a particular side branch.

9A-9C show a user display that integrates a side view of a three-dimensional rendering (FIG. 9A), a corresponding B-mode OCT image (FIG. 9B), and a corresponding L-mode OCT image (FIG. 9C). showing. FIG. 9A is a side view of a three-dimensional rendering of blood vessel 300. FIG. Guidewire 302 and stent struts 304 are visible. FIG. 9B shows a cross-sectional B-mode OCT image. A guidewire shadow 312 and a number of stent strut shadows 314 are clearly visible. FIG. 9C shows a longitudinal L-mode OCT image. The guidewire shadow 312 and numerous stent strut shadows are clearly visible. A vertical line 316 defines the cross-sectional frame shown in FIG.

Figures 10A-10C integrate a three-dimensional rendering aspect (Figure 10A), a corresponding B-mode OCT image (Figure 1B), and a corresponding L-mode OCT image (Figure 10C) similar to Figures 9A-9C. 1 shows a user display with FIG. 10A includes visible markings 306 defining constrained side branches.

11A-11C show a user display that integrates a fly-through rendering (FIG. 11A), a corresponding B-mode OCT image (FIG. 11B), and a corresponding L-mode OCT image (FIG. 10C). In FIG. 11A, guidewire 302 and stent struts 304 are shown in a space-filling model. A compass 320 indicates the proximal and distal directions.

Figures 12A-12C show a display similar to that shown in Figures 12A-12C. FIG. 12A includes markings of constrained side branch 306 in accordance with an exemplary embodiment.

13A-13C show a side view of a three-dimensional rendering (FIG. 13A), a corresponding B-mode OCT image (FIG. 13B), and a corresponding L-mode OCT image (FIG. 13C) similar to FIGS. 9A-9C. Figure 3 shows an integrated user display. FIG. 13A shows the side branch ostium 322 constrained but unoccluded by cutting the stent struts 324 that constrained the side branch. FIG. 13D is an enlarged view of FIG. 13A showing side branch ostium 322 and cleaved strut 324 .

Exemplary Intravascular Data Acquisition Embodiments The systems and methods described herein are of particular clinical application for bifurcation, BVS, VFR for other complex conditions such as tandem lesions/diffuse disease. provide diagnostic information to support pre- and post-interventional imaging needs. These embodiments include the following features.
● 3D options for fly-through, longitudinal and branch views ● OCT use and stent detection for BVS procedural considerations ● Ultra-high resolution pullback for bifurcation cases ● Independent wires on 3D in addition to numerous 3D viewing options Selection ● Stent apposition mapping indicator; addition of status bar for 360 degree assessment ● Arrangement indication ranges for red/yellow and customizable ability to adjust those ranges ● Various user interface design elements

FIG. 14A shows an interface display illustrating a three-dimensional skin and wireframe view of a stent placed based on OCT imaging data. The upper left panel shows a frontal view of the vessel, specifically the intraluminal boundary of the vessel is depicted in three dimensions as translucent skin. The skin estimates or approximates the topography of the vessel wall and/or vessel lumen along the region of interest. In preferred embodiments, the skin closely approximates the contours of the side branches to enhance the user's visualization of vascular topography, such as side branches, healthy endothelium, stenosis, lesions, and plaque. The skin can be painted in any suitable color and is preferably translucent to allow visualization of the stent positioned within the lumen.

Similar to other user interfaces, double arrows allow the user to rotate the skin view. As shown in FIG. 14A, in some embodiments, the skin itself has no thickness (ie, is two-dimensional) and only defines the luminal boundary in three dimensions. In other embodiments, the skin may have a nominal or substantial thickness to improve feature visualization. The transparency level of lumens, skin or other layers can be adjusted to enhance the overlay of features such as stent struts. As shown in FIG. 14B, collateral detection is enhanced using a three-dimensional interface to support the branching procedure as well as inputs to the VFR calculation.

With continued reference to FIG. 14A, the upper left panel shows the deployed stent as a wireframe graphic behind or inside translucent skin. The side branch ostium appears as a hole or opening in the skin. The stent struts are visible through the translucent skin. Stent struts can be indicated by color or other visual markings to provide additional information regarding stent placement and positioning. For example, properly placed struts are shown in one color (e.g., white), and poorly apposed (poor apposition) (e.g., inadequately distended, collateral branch, etc.) struts are shown in a different color (e.g., white). red). The degree or extent of stent apposition can be conveyed by a color gradient such as white for proper placement, yellow for potential apposition, and red for possible stent apposition. Different colors can also be used to distinguish between different causes of misalignment and associated alignment levels or thresholds. For example, these thresholds can be set using the user interface in one embodiment as shown in FIGS. 15A-15C. One or more software modules 67 can be used to implement the software and controllers to display the indicia.

As a non-limiting example, stent struts that are adequately expanded against the vessel wall are shown in one color (e.g., white), while struts that are inadequately expanded are shown in another color (e.g., purple). It can be shown to alert the user that further intervention may be required to fully expand the stent at a particular location. Similarly, struts that constrain or occlude the side branch ostium are shown in yet another color (e.g., red), and potentially constrained struts are shown in yet another color (e.g., yellow) to facilitate stent adjustment or The user can be warned that relocation may be required. As will be appreciated, other visual indicia can be used, such as patterned lines, hatching and shading.

The upper right panel of FIG. 14A shows a cross-section of the OCT image. Cross-sections of stent struts are depicted as circles. The stent struts can be indicated by color or other visible markings to inform the user regarding the positioning of the struts. For example, stent struts that are properly expanded against the vessel wall are shown in one color (eg, white), while struts constraining side branches are shown in another color (eg, red).

The middle panel of FIG. 14A shows a longitudinal or L-mode rendering of the OCT data. The cross-sectional frame corresponds to vertical lines within the region of interest. The bottom panel of FIG. 14A shows a wireframe representation of the deployed stent and an OCTL mode image of the vessel co-registered. Again, stent struts properly expanded against the vessel wall are shown in one color (eg, white), while struts constraining side branches are shown in another color (eg, red).

FIG. 14C shows an interface display illustrating a three-dimensional skin and wireframe view of a stent placed based on OCT imaging data. User displays may include options to show or hide one or more features such as skin, guidewires, and/or stent struts. Additionally, the color and transparency of the skin can be changed to make the skin more transparent or opaque.

FIG. 14D shows a fly-through display illustrating a three-dimensional skin and wireframe view of the deployed stent. The distal (D) or downstream direction and the proximal (P) or upstream direction are indicated. The interface display can also include position markers that indicate the location of the cross-sectional image within the region of interest. The interface display may further include lumen markers that highlight lumen boundaries/contours to better reveal vessel topography.

FIG. 14E shows a fly-through display illustrating a three-dimensional wireframe view of the deployed stent. In this embodiment, the skin is not shown, leaving only the stent struts and guidewire. In some situations, stent apposition may be more apparent when the skin is not shown. The skin can be switched on and off as part of a 3D view and 3D flythrough to the lumen along the length of the vessel.

User interface features for apposition levels The process of establishing stent apposition values, such as apposition thresholds, may differ from one end user of an intravascular diagnostic system to another. The end-user can adjust the apposition threshold for the stent using an interface such as that shown in Figures 15A, 15B, and 15C. In FIG. 15A, the user interface for adjusting stent apposition values is shown relative to the graphical user interface of the OCT system. This interface can be used for IVUS and other imaging modalities. Stent struts shown by dashed lines have arrows that can extend to one or more surfaces or stent struts as variable features. This allows juxtapositions to be identified to locations on or within the strut as of interest to the user. In Figures 15A and 15B, three levels or thresholds for scoring or specifying juxtaposition levels are between 0-200 microns, 200-300 microns, and 300-600 microns. As shown in FIG. 15B, the three colored bars shown allow three alignment thresholds to be set. These thresholds control when and how stent apposition is displayed. The strut apposition distance is indicated by the double headed arrows in the figures for the stent struts and lumen contour.

A lumen contour is the detected or calculated boundary of the lumen of a blood vessel. Preferably, the stent struts approximate the luminal contour. As long as the strut apposition indicates that the anterior surface of the strut is at a known distance from the luminal contour, the end user uses knowledge of the stent thickness to set the apposition threshold to meet their individual needs. be able to. The alignment threshold can be set as in FIG. Only two levels appear - juxtaposed or not juxtaposed. Two, three or more such levels can be set. In one embodiment, as shown in FIGS. 15A and 15B, the slider bar is adjusted to set the apposition (poor apposition) threshold such that three indicators are used to modify the stent strut graphics. The term apposition can include malapposition as used to describe the extent to which a stent deviates from its preferred level of expansion or placement relative to the vessel wall.

A user interface can be used to define the level of stent misalignment, such as by an apposition threshold for evaluating the detected stent struts against the detected lumen contour. The interface includes slider or toggle controls (shown in FIGS. 15A-15C), one or more buttons, percentage or distance of other apposition parameters, fields for entry, or stent struts and stents where markings have been detected. There may be other user interfaces, such as other interfaces that specify how they are displayed with respect to strut apposition level. Any suitable interface for selecting or entering alignment thresholds can be used. In one embodiment, apposition does not specify stent strut thickness, but rather uses stent strut end surfaces. In this way, end-users can adjust the threshold based on their expertise and the thickness of the stent struts in use.

Non-limiting Software Features and Embodiments Implementing Interfaces, Detection and Other Features of the Disclosure The following description describes device hardware and other operating components suitable for performing the disclosed methods described herein. intended to provide an overview of This description is not intended to limit the applicable environment or scope of the disclosure. Similarly, hardware and other operational components may be suitable as part of the devices described above. The present disclosure can be practiced in other system configurations, including personal computers, multiprocessor systems, microprocessor-based or programmable electronic devices, network PCs, minicomputers, mainframe computers, and the like. The present disclosure may also be practiced in distributed computing environments where tasks are performed by remote processing devices that are linked through a communications network, such as different rooms in a catheterization or catheterization laboratory.

Some portions of the detailed description are presented in terms of algorithms and symbolic representations of operations on data bits within a computer memory. These algorithmic descriptions and representations may be used by those skilled in the computer- and software-related arts. In one embodiment, algorithms herein are generally conceived to be self-consistent sequences of actions that yield desired results. The method steps or operations performed as otherwise described herein require physical manipulations of physical quantities. Usually, though not necessarily, these quantities take the form of electrical or magnetic signals capable of being stored, transferred, combined, transformed, compared, and otherwise manipulated.

Throughout this description, unless otherwise stated, as will be apparent from the discussion below, "process" or "calculate" or "search" or "display" or "detect" or "measure" or "calculate" Discussions utilizing terms such as "do" or "compare" or "generate" or "detect" or "determine" or "display" or Boolean logic or other set-related operations or the like , manipulating data represented as physical (electronic) quantities in registers and memories of computer systems or electronic devices, and converting them as physical quantities in electronic memories or registers or other such information storage, transmission or display devices Refers to the actions and processes of a computer system or electronic device that transforms other data represented by

The present disclosure also relates, in some embodiments, to an apparatus for performing the operations herein. This apparatus may be specially constructed for the required purposes, or it may comprise a general purpose computer selectively activated or reconfigured by a computer program stored in the computer. Various circuits and their components can be used to perform some of the data collection and conversion and processing described herein.

The algorithms and displays presented herein are not inherently related to any particular computer or other apparatus. Various general-purpose systems may be used with programs in accordance with the teachings herein, or it may prove convenient to construct more specialized apparatus to perform the required method steps. . The required structure for a variety of these systems will appear from the description provided herein. Additionally, the present disclosure is not described with reference to any particular programming language, and thus various embodiments may be implemented using various programming languages. In one embodiment, the software instructions are configured for operation in a microprocessor or ASIC of an intravascular imaging/data acquisition system.

Embodiments of the present disclosure include, but are not limited to, computer program logic for use with processors (e.g., microprocessors, microcontrollers, digital signal processors, or general purpose computers), programmable logic devices (e.g., field programmable Any other means including program logic, discrete components, integrated circuits (e.g., application specific integrated circuits (ASICs)), or any combination thereof for use with gate arrays (EPGAs) or other PLDs) , may be implemented in many different forms.

In an exemplary embodiment of the present disclosure, one of processing data collected using OCT probes, IVUS probes, other imaging probes, angiography systems, and other imaging and subject monitoring devices and processor-based systems. Part or all may be implemented as a set of computer program instructions converted to computer-executable form and stored as such in a computer-readable medium and executed by a microprocessor under control of an operating system. Thus, for example, user interface commands and triggers based on completion of a pullback or co-registration request are suitable for generating OCT data and performing image processing using the various and other features and embodiments described above. , are translated into processor-understandable instructions.

In addition, the user interface commands, user queries, system responses, transmitted probe data, input data and other data and signals described herein are responsive to user interface selections, control graphical user interfaces, and graphical signal processing. , displays cross-sectional information, rendered images from stents and guidewires and other data acquisition modalities, generates and displays stents and apposition bars and other intravascular data, displays OCT, angiography and converted into processor understandable instructions suitable for detecting shadows and detecting peaks and other data such as graphic user interfaces and other features and portions of embodiments as described above. GUI components or controls, data and parameters suitable for display as values or as other representations in a graphical user interface include guidewires, apposition bars, user interface panels, masks, stent struts, missing data representations, shading, Including, but not limited to, angiographic representations, 3D and 2D renderings and views, and other features described herein.

Computer program logic implementing all or part of the functionality described herein may be in source code form, computer-executable form and various intermediate forms (e.g., assemblers, compilers, linkers, locators). may be embodied in a variety of forms, including but not limited to forms produced by ). Source code may be written in any of various programming languages (e.g., object code, assembly language, or high-level languages such as Fortran, C, C++, JAVA, or HTML) for use with various operating systems or operating environments. It may comprise a series of computer program instructions implemented in a The source code may define and use various data structures and communication messages. The source code may be in computer-executable form (eg, via an interpreter), or the source code may be converted to computer-executable form (eg, via a translator, assembler, or compiler). .

The computer program may be stored on semiconductor memory devices (eg RAM, ROM, PROM, EEPROM, or flash programmable RAM), magnetic memory devices (eg diskettes or fixed disks), optical memory devices (eg CD-ROM), PC cards (eg , PCMCIA card), or other memory device, permanently or temporarily fixed in any form (e.g., source code form, computer-executable form, or intermediate form) good. A computer program can be any of a variety of communication technologies including, but not limited to, analog, digital, optical, wireless (e.g., Bluetooth), networking, and internetworking technologies. can be fixed to any form of signal that can be sent to a computer using . A computer program may be a printed or electronic document (e.g., a , shrinkwrap software) in any form as a removable storage medium.

Hardware logic (including programmable logic for use with programmable logic devices) implementing all or part of the functionality described herein may be designed using conventional manual methods, or electronically designed and captured using various tools such as computer aided design (CAD), hardware description languages (e.g. VHDL or AHDL), PLD programming languages (e.g. PALASM, ABEL, or CUPL) , may be simulated or documented.

Programmable logic may be semiconductor memory devices (eg, RAM, ROM, PROM, EEPROM, or flash programmable RAM), magnetic memory devices (eg, diskettes or fixed disks), optical memory devices (eg, CD-ROM), or other memory devices. It may be permanently or temporarily affixed to a tangible storage medium, such as a device. Programmable logic may be any of a variety of communication technologies including, but not limited to, analog, digital, optical, wireless (e.g., Bluetooth), networking, and internetworking technologies. may be fixed in a signal that can be sent to a computer using Programmable logic may be preloaded into a computer system (e.g., on a system ROM or fixed disk) or distributed from an electronic bulletin board or server through a communication system (e.g., the Internet or the World Wide Web) in printed or electronic documents (e.g. , shrinkwrap software).

Various examples of suitable processing modules are described in more detail below. As used herein, module refers to software, hardware, or firmware suitable for performing a particular data processing or data transmission task. In one embodiment, the module provides commands or angiographic data, OCT data, IVUS data, offsets, shadows, pixels, intensity patterns, guidewire segments, side branch orientation, stent orientation, stent position relative to side branch location, user interface data, control signals, angiography data, user motion, frequency, interferometer signal data, detected stents, candidate stent struts, IVUS data, shadows, pixels, intensity patterns, scores, projections, and guidewire data and herein Refers to software routines, programs, or other memory-resident applications suitable for receiving, transforming, routing, and processing various types of data, such as other information of interest as described .

The computers and computer systems described herein are operatively associated computer-readable memory, such as memory, for storing software applications used to acquire, process, store, and/or communicate data. May contain media. It will be appreciated that such memory may be internal, external, remote or local to the computer or computer system with which it is operatively associated.

The memory may be, for example, without limitation, a hard disk, an optical disk, a floppy disk, a DVD (digital versatile disk), a CD (compact disk), a memory stick, a flash memory, a ROM (read only memory), a RAM (Random Access Memory), DRAM (Dynamic Random Access Memory), PROM (Programmable ROM), EEPROM (Extended Erasable PROM), and/or other equivalent computer readable media. Any means for storing may be included.

Generally, computer-readable memory media as applied in connection with the disclosed embodiments described herein may include any memory media capable of storing instructions for execution by a programmable device. Where applicable, method steps described herein may be embodied or executed as instructions stored on a computer-readable storage medium or storage medium. These instructions may be embodied in various programming languages, such as C++, C, Java, and/or various other types of software programming languages that may be applied to create instructions according to embodiments of the present disclosure. software.

The terms "machine-readable medium" or "computer-readable medium" are capable of storing, encoding, or otherwise carrying a set of instructions for execution by a machine, and any of the methodologies of the present disclosure may be applied to the machine. It includes any medium that causes one or more to occur. Although the machine-readable medium is illustrated in the exemplary embodiment as being a single medium, the term "machine-readable medium" refers to a single medium or multiple media that store one or more sets of instructions. It should be understood to include media (eg, databases, one or more centralized or distributed databases and/or associated caches and servers).

A storage medium may be or include a non-transitory device. Thus, non-transitory storage media or non-transitory devices may include devices that are tangible, meaning that the device has a specific physical form, but that the device cannot change its physical state. You can Thus, for example, non-transitory refers to devices that remain tangible despite this change of state.

The aspects, embodiments, features, and examples of the disclosure are to be considered illustrative in all respects and are not intended to limit the disclosure, the scope of which is defined only by the claims. Other embodiments, modifications and applications will be apparent to those skilled in the art without departing from the spirit and scope of the claimed invention.

The use of headings and sections in this application is not meant to limit the invention. Each section may apply to any aspect, embodiment, or feature of the claimed invention.

Throughout this application, when a composition is described as having, includes, or includes a particular component, or when a process is described as having, includes, or includes a particular process step, the It will be understood that the composition consists essentially of or consists of the enumerated components and that the processes of the present teachings consist essentially of or consist of the enumerated process steps.

In this application, when an element or component is said to be included in and/or selected from a list of enumerated elements or components, the element or component is any one of the enumerated elements or components. and may be selected from the group consisting of two or more of the listed elements or components. Furthermore, elements and/or features of the compositions, devices, or methods described herein, whether express or implied herein, may be varied without departing from the spirit and scope of the present teachings. It should be understood that they can be combined in any way.

Use of the terms “include,” “includes,” “including,” “have,” “has,” or “having” is expressly Unless otherwise specified, it should be understood to be generally open-ended and non-limiting.

The use of the singular herein includes the plural (and vice versa) unless specifically stated otherwise. Moreover, the singular forms "a," "an," and "the" include plural forms unless the context clearly dictates otherwise. Additionally, where the use of the term "about" precedes a quantitative value, the present teachings also include the particular quantitative value itself, unless otherwise indicated. As used herein, the term "about" refers to ±10% variation from the nominal value.

It should be understood that the order for performing certain actions or the order of steps is immaterial so long as the present teachings remain operable. Moreover, two or more steps or actions may be conducted simultaneously. The examples presented herein are intended to illustrate potential specific implementations of the present disclosure. It can be understood that these examples are intended primarily for purposes of illustration of the disclosure for those skilled in the art. Changes may be made to these figures or the operations described herein without departing from the spirit of the disclosure. For example, in certain cases, method steps or operations may be performed or performed in a different order, or operations may be added, deleted, or modified.

When a range or list of values is provided, each intervening value between the upper and lower limits of such pairwise range or list is individually contemplated, and each value specifically recited herein. are included in the present invention as if. In addition, smaller ranges between and including the upper and lower limits of any given range are envisioned and are encompassed within the invention. A listing of exemplary values or ranges does not exclude other values or ranges between and including the upper and lower limits of a given range.

Moreover, although specific embodiments of the present disclosure have been described herein for the purposes of illustrating the present disclosure and not for the purpose of limiting the present disclosure, elements, steps, structures, and/or It will be appreciated by those skilled in the art that many variations in the details, materials and arrangements of parts may be made within the principles and scope of the present disclosure without departing from the disclosure as set forth in the claims. be.

Moreover, specific embodiments of the present disclosure are described herein for the purpose of exemplifying the disclosure and not for the purpose of limiting the same, but may include elements, steps, structures, and/or components. It will be understood by those skilled in the art that many variations in detail, materials and arrangements may be made within the principles and scope of the present disclosure without departing from the disclosure set forth in the claims.

What is claimed is as follows.

What is claimed is as follows.
In addition, in order to maintain the disclosure matters of the original filing of the present application, the descriptions of claims 1 to 20 of the original filing of the present application are added below.
(Claim 1)
A method of visualizing intravascular information obtained using an intravascular data acquisition probe, comprising:
receiving intravascular data for the vessel comprising a plurality of image frames;
storing the intravascular data in a memory device of the intravascular data acquisition system;
detecting one or more side branches per image frame;
detecting the lumen for each image frame;
determining a first viewing angle for at least one of the side branch or the lumen;
displaying a three-dimensional visualization of at least one of the side branch or the lumen;
a method comprising:
(Claim 2)
2. The method of claim 1, wherein the lumen is a lumen boundary.
(Claim 3)
2. The method of claim 1, further comprising displaying a three-dimensional flythrough for at least one of the side branch or the lumen.
(Claim 4)
2. The method of claim 1, wherein the intravascular data is optical coherence tomography data.
(Claim 5)
5. The method of claim 4, wherein each image frame comprises a set of scanlines.
(Claim 6)
2. The method of claim 1, further comprising detecting multiple stent struts.
(Claim 7)
2. The method of claim 1, further comprising detecting one or more guidewires.
(Claim 8)
7. The method of claim 6, further comprising determining a second viewing angle for the plurality of stent struts.
(Claim 9)
8. The method of claim 7, further comprising determining a third viewing angle for the one or more guidewires.
(Claim 10)
2. The method of claim 1, wherein said three-dimensional visualization is oriented at said first viewing angle.
(Claim 11)
4. The method of claim 3, wherein the three-dimensional flythrough is user-controllable in one or more directions using an input device.
(Claim 12)
determining a collateral arc of the lumen contour;
estimating the side branch orientation by fitting a cylinder constrained by the side branch arc;
selecting the orientation of the cylinder to be adapted;
2. The method of claim 1, further comprising:
(Claim 13)
Determining an intermediate frame of an image frame of intravascular data, determining an intermediate arc position on said intermediate frame, and determining an initial camera position for a three-dimensional view to orient towards an intravascular imaging probe for said intermediate frame. 2. The method of claim 1, further comprising the step of setting .
(Claim 14)
A processor-based system for controlling a stent apposition threshold based on user input, comprising:
one or more memory devices;
a computing device in communication with the one or more memory devices;
comprising
The one or more memory devices contain instructions executable by the computing device, the instructions directing the computing device to:
displaying a user interface including a stent strut apposition threshold control including user-selectable inputs;
having one or more memory devices store user-input stent strut apposition thresholds;
detecting one or more stents within an intravascular data set collected using an intravascular probe;
displaying one or more stents and one or more indicia associated with the one or more stents, the indicia indicating the level of stent strut apposition determined using the user-selectable input;
is the system
(Claim 15)
15. The method of claim 14, wherein the stent strut apposition threshold control is a slider.
(Claim 16)
16. The method of claim 15, wherein the user-selectable input is one or more values of the slider.
(Claim 17)
15. The method of claim 14, wherein the indicia are one or more colors.
(Claim 18)
16. The method of claim 15, wherein the slider is configured to define three co-alignment thresholds.
(Claim 19)
2. The method of claim 1, wherein the stent strut apposition threshold control measures stent strut apposition to an anterior surface of the stent strut.
(Claim 20)
2. The method of claim 1, wherein the stent strut apposition threshold control is selected from the group consisting of form-fillable fields, buttons, toggle controls, dials, and numerical selection inputs.

1 shows a schematic diagram of an intravascular imaging and data acquisition system in accordance with an exemplary embodiment of the present disclosure; FIG. 4 is a flow chart illustrating a framework for visualization of a stent within a branch vessel in accordance with an exemplary embodiment of the present disclosure; FIG. 12A is a schematic diagram illustrating virtual camera positions for visualizing a side branch vessel in accordance with an exemplary embodiment of the present disclosure; FIG. 12A is a schematic diagram illustrating virtual camera positions for visualizing a side branch vessel in accordance with an exemplary embodiment of the present disclosure; FIG. 12A is a schematic diagram illustrating virtual camera positions for orthogonal viewing of a side branch ostium in accordance with an exemplary embodiment of the present disclosure; 3D is a three-dimensional rendering of a stent strut constraining a side branch ostium in accordance with an exemplary embodiment of the present disclosure; FIG. 12A is a side view of a three-dimensional rendering of a main vessel having side branches with a stent and multiple guidewires positioned within the main vessel, in accordance with an exemplary embodiment of the present disclosure; 3B is a fly-through three-dimensional rendering of the side branch lumen with the virtual camera angle directed along the longitudinal axis of the side branch as shown in FIG. 3A, according to an exemplary embodiment of the present disclosure; 3B is a fly-through three-dimensional rendering of the main vessel lumen with the virtual camera angle oriented along the longitudinal axis of the main vessel as shown in FIG. 3A, according to an exemplary embodiment of the present disclosure; FIG. 4 is a schematic diagram illustrating virtual camera positioning with an intermediate frame/intermediate arc model in accordance with an exemplary embodiment of the present disclosure; Fig. 10 is a schematic diagram showing a virtual camera positioning using a cylinder model; FIG. 11 is a schematic diagram illustrating side branch size estimation according to an exemplary embodiment of the present disclosure; FIG. 12 is a schematic diagram showing side branch locations and color coding the degree of side branch occlusion in accordance with an exemplary embodiment of the present disclosure; 4 is a user display showing a perspective view of a three-dimensional rendering of a blood vessel in accordance with an exemplary embodiment of the present disclosure; FIG. 3A is a side view of a three-dimensional rendering of a blood vessel in accordance with an exemplary embodiment of the present disclosure; 4 is a cross-sectional B-mode OCT intravascular image in accordance with an exemplary embodiment of the present disclosure; 4 is a longitudinal L-mode OCT intravascular image in accordance with an exemplary embodiment of the present disclosure; FIG. 13A is a side view of a three-dimensional rendering of a blood vessel showing constrained side branches in accordance with an exemplary embodiment of the present disclosure; 4 is a cross-sectional B-mode OCT intravascular image in accordance with an exemplary embodiment of the present disclosure; 4 is a longitudinal L-mode OCT intravascular image in accordance with an exemplary embodiment of the present disclosure; 3 is a fly-through three-dimensional rendering of a blood vessel in accordance with an exemplary embodiment of the present disclosure; 4 is a cross-sectional B-mode OCT intravascular image in accordance with an exemplary embodiment of the present disclosure; 4 is a longitudinal L-mode OCT intravascular image in accordance with an exemplary embodiment of the present disclosure; 3 is a fly-through three-dimensional rendering of a vessel showing constrained side branches in accordance with an exemplary embodiment of the present disclosure; 4 is a cross-sectional B-mode OCT intravascular image in accordance with an exemplary embodiment of the present disclosure; 4 is a longitudinal L-mode OCT intravascular image in accordance with an exemplary embodiment of the present disclosure; FIG. 13A is a side view of a three-dimensional rendering of a blood vessel showing a released side branch in accordance with an exemplary embodiment of the present disclosure; FIG. 13B is a cross-sectional B-mode OCT intravascular image in accordance with an exemplary embodiment of the present disclosure; FIG. 13C is a longitudinal L-mode OCT intravascular image in accordance with an exemplary embodiment of the present disclosure; FIG. 13D is an enlarged view of FIG. 13A showing a side branch ostium and torn stent struts according to an exemplary embodiment of the present disclosure; FIG. 13B shows a graphical user interface display of an intravascular data acquisition system illustrating a three-dimensional skin and wireframe view of a deployed stent in accordance with an exemplary embodiment of the present disclosure; FIG. FIG. 13B shows a graphical user interface display of an intravascular data acquisition system illustrating a three-dimensional skin and wireframe view of a deployed stent in accordance with an exemplary embodiment of the present disclosure; FIG. FIG. 13B shows a graphical user interface display of an intravascular data acquisition system illustrating a three-dimensional skin and wireframe view of a deployed stent in accordance with an exemplary embodiment of the present disclosure; FIG. FIG. 13B shows a graphical user interface display of an intravascular data acquisition system illustrating a three-dimensional skin and wireframe view of a deployed stent in accordance with an exemplary embodiment of the present disclosure; FIG. FIG. 12B shows a three-dimensional fly-through display of a wireframe view of a deployed stent according to an exemplary embodiment of the present disclosure; FIG. A user interface suitable for adjusting the alignment threshold, which then determines when to display alignment and indications/indicia (colors, symbols, etc.) for use in accordance with exemplary embodiments of the present disclosure. 4 is a user interface that controls the threshold used by the intravascular data acquisition system when determining . A user interface suitable for adjusting the alignment threshold, which then determines when to display alignment and indications/indicia (colors, symbols, etc.) for use in accordance with exemplary embodiments of the present disclosure. 4 is a user interface that controls the threshold used by the intravascular data acquisition system when determining . A user interface suitable for adjusting the alignment threshold, which then determines when to display alignment and indications/indicia (colors, symbols, etc.) for use in accordance with exemplary embodiments of the present disclosure. 4 is a user interface that controls the threshold used by the intravascular data acquisition system when determining .

Claims (20)

A method of visualizing intravascular information obtained using an intravascular data acquisition probe, comprising:
receiving intravascular data for the vessel comprising a plurality of image frames;
storing the intravascular data in a memory device of the intravascular data acquisition system;
detecting one or more side branches per image frame;
detecting the lumen for each image frame;
determining a first viewing angle for at least one of the side branch or the lumen;
displaying a three-dimensional visualization of at least one of said side branch or said lumen. 2. The method of claim 1, wherein the lumen is a lumen boundary. 2. The method of claim 1, further comprising displaying a three-dimensional flythrough for at least one of the side branch or the lumen. 2. The method of claim 1, wherein the intravascular data is optical coherence tomography data. 5. The method of claim 4, wherein each image frame comprises a set of scanlines. 2. The method of claim 1, further comprising detecting multiple stent struts. 2. The method of claim 1, further comprising detecting one or more guidewires. 7. The method of claim 6, further comprising determining a second viewing angle for the plurality of stent struts. 8. The method of claim 7, further comprising determining a third viewing angle for the one or more guidewires. 2. The method of claim 1, wherein said three-dimensional visualization is oriented at said first viewing angle. 4. The method of claim 3, wherein the three-dimensional flythrough is user-controllable in one or more directions using an input device. determining a collateral arc of the lumen contour;
estimating the side branch orientation by fitting a cylinder constrained by the side branch arc;
2. The method of claim 1, further comprising: selecting the orientation of the cylinder to be adapted. Determining an intermediate frame of an image frame of intravascular data, determining an intermediate arc position on said intermediate frame, and determining an initial camera position for a three-dimensional view to orient towards an intravascular imaging probe for said intermediate frame. 2. The method of claim 1, further comprising the step of setting . A processor-based system for controlling a stent apposition threshold based on user input, comprising:
one or more memory devices;
a computing device in communication with the one or more memory devices;
The one or more memory devices contain instructions executable by the computing device, the instructions directing the computing device to:
displaying a user interface including a stent strut apposition threshold control including user-selectable inputs;
having one or more memory devices store user-input stent strut apposition thresholds;
detecting one or more stents within an intravascular data set collected using an intravascular probe;
displaying one or more stents and one or more indicia associated with the one or more stents, the indicia indicating the level of stent strut apposition determined using the user-selectable input; system 15. The method of claim 14, wherein the stent strut apposition threshold control is a slider. 16. The method of claim 15, wherein the user-selectable input is one or more values of the slider. 15. The method of claim 14, wherein the indicia are one or more colors. 16. The method of claim 15, wherein the slider is configured to define three co-alignment thresholds. 2. The method of claim 1, wherein the stent strut apposition threshold control measures stent strut apposition to an anterior surface of the stent strut. 2. The method of claim 1, wherein the stent strut apposition threshold control is selected from the group consisting of form-fillable fields, buttons, toggle controls, dials, and numerical selection inputs.

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